Burst Spinal Cord Stimulation for Neuropathic Pain.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Lower Back Pain
- Peripheral Neuropathic Pain
- Radiculopathy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: N-of-1-study. Each patient will go through three treatment cycles each consisting of two weeks of active treatment and two weeks of sham in randomised order. In total the study period will be 12 weeks.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
SCS is a treatment offered to patients with peripheral neuropathic pain, and involves electrical stimulation of the spinal cord. The analgesic effect is possibly mediated via both spinal and supra-spinal mechanisms. Traditional "tonic" SCS causes paresthesia during treatment, but the newer burst tec...
SCS is a treatment offered to patients with peripheral neuropathic pain, and involves electrical stimulation of the spinal cord. The analgesic effect is possibly mediated via both spinal and supra-spinal mechanisms. Traditional "tonic" SCS causes paresthesia during treatment, but the newer burst technique (five electrical pulses at 500Hz delivered in intermittent packets of 40 Hz) can be performed below detection level. Thus, it is possible to do double-blinded sham-controlled studies. In this study, we will study the effect of burst SCS compared with sham on pain intensity and function (Patient-Specific Functional Scale). In addition, we will use several questionnaires (psychometric data, health-related quality of life, sleep, global impression of change, use of analgesics, blinding).
Tracking Information
- NCT #
- NCT03733886
- Collaborators
- Uppsala University Hospital
- Investigators
- Principal Investigator: Bård Lundeland, PhD Department of Pain Management and Research, Oslo University Hospital
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